GlobalData on MSN24d
iRhythm secures 510(k) clearance for Zio device updates after FDA warning
named the Zio AT patch, with the ZEUS system, iRhythm’s AI-powered software for ECG analysis. This latest update comes after ...
MassDevice15d
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
Rhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and ...
medtechdive14d
FDA clears iRhythm’s second 510(k) in response to warning letter
However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...
Yahoo Finance23d
iRhythm’s Zio AT design changes win FDA clearance
The Food and Drug Administration cleared prior design modifications for iRhythm Technologies ... second in “the near future.” The Zio AT wireless patch device is cleared by the FDA for ...
iRhythm announces results of EXAMINE-HCM study
Technologies announced that the results of the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk ...
Business Insider25d
iRhythm Technologies Receives FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device
SAN FRANCISCO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and ...
Benzinga.com24d
With FDA Approval iRhythm May Be Able To Lift Regulatory Overhang, Investor Skepticism, Analyst Says
FDA clears iRhythm's first 510(k) submission for Zio AT device; second approval expected soon. Zio AT provides mobile cardiac telemetry for up to 14 days, aiding in ECG monitoring. On Monday, the ...